Industry news

Russian government to start checks for GMP compliance of domestic drug producers

ThePharmaLetter

The Russian government plans to start massive checks of the domestic producers of drugs, as well as drug importers for their compliance of products with Good Manufacturing Practices (GMP) standards, which became mandatory in Russia since the beginning of the current year, according to an official representative of the Russian Ministry of Industry and Trade.

Pharma's top 10 M&A deals of 2014's first half

Eric Palmer, Feirce Pharma

Mergers and acquisitions have been non-stop this year, with lots of deals done, and some doozies that were unable to cross the finish line. Here we look at what's happened in the first half of the year; we will round out the entire year's activity in another report early next year.

Pharma deploys reps with helping hands to target stealth prescribers

Emily Wasserman, Fierce PharmaMarketing

As physicians pack up camp and move to larger healthcare systems, restrictive policies bar reps from calling on doctors and face-to-face conversations dwindle. But companies may want to invite other members of the office to the marketing party--and send specialized reps to offer a few favors.

HHS and NIH take steps to enhance transparency of clinical trial results

USA - National Institutes of Health

The U.S. Department of Health and Human Services today issued a Notice of Proposed Rulemaking (NPRM), which proposes regulations to implement reporting requirements for clinical trials that are subject to Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). 

US government proposes rules to increase transparency of clinical trials

FirstWorld Pharma

The US Department of Health and Human Services (HHS) proposed new rules on Wednesday that would increase the number of clinical trials that drugmakers, medical device companies and academic researchers are required to report. "We owe it to every participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health," remarked National Institutes of Health (NIH) director Francis Collins.

Cost to Develop a Drug More Than Doubles to $2.56 Billion

Anna Edney, Bloomberg

It costs drugmakers $2.56 billion to bring a new medicine to market, on average, more than double the price of 11 years ago, according to a study released today. The higher cost comes from clinical trials that are larger and more complex, as well as more drugs that fail in development, according to the researchers. While the Food and Drug Administration is sometimes blamed for driving up costs because of the time it takes to review new drugs, that wasn’t a factor, according to the study by the Tufts Center for the Study of Drug Development.

Russia’s Tomsk keen to garner share of Indian pharma market, as its business delegation visits 3 Indian cities

Pharmabiz.com

Russia’s Tomsk region known for its pharmaceuticals and chemicals have evinced interest for collaborations and joint ventures with Indian companies. A business delegation of small and medium companies from the Tomsk Region, Russia was here in Bengaluru, Mumbai and New Delhi to ascertain the growth prospects.

18 November 2014

Epic Sciences to Present Data on a Combination CTC and cfDNA Assay for Molecular Targets of Non-Small Cell Lung Cancer Therapies at the 26th EORTC-NCI-AACR Symposium

Epic Sciences will present data describing the detection of clinically actionable non-small cell lung cancer (NSCLC) biomarkers, including EGFR, KRAS, ALK, MET, RET and ROS1, utilizing both circulating tumor cells (CTC) and circulating free DNA (cfDNA) from a single tube of blood. The poster presentation will take place on November 20 at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona. 

Innovation drug manufacturing site launched in Moscow

MARCHMONT Innovation News

A new production line has opened in Moscow’s Strogino Technopark to synthesize innovation drugs, the website of Moscow’s TVTs TV channel reported. 

Kremlin opts not to sanction U.S.-Russia scientific ties, Russian ambassador said

MARCHMONT Innovation News

The Russian government is not imposing any sanctions whatsoever against the U.S. in the field of scientific interaction, Gazeta.ru  reported, citing Ambassador Sergey Kislyak of the Russian Federation.